New Product Development Processes for IOT-Enabled Home Use Medical Devices: A Systematic Review

Background: In the new forefront of healthcare at patients’ homes, medical devices developed to use at home setting by lay users are essential. The adoption of home-use medical devices will benefit both patients and public healthcare services in terms of quality of life, enhanced outcomes, and reduced cost of care. Home use medical devices associated with Internet-Of-Things (IOT) technology assists patients in performing self-care as well as providing health information remotely to health care professionals. However, adopting technology requires understanding the nature of the medical device and medical device development (MDD). Existing studies concerning the new product development (NPD) processes or design processes were systematically reviewed to explore knowledge and expertise to provide a framework for IOT engineers or designers to adopt IOT technology to home use medical devices. Objective: This study aimed to review the published literature to explore the current studies in the field of the NPD process, design process, design methodology, and outcome of the device affecting user acceptance. Methods: A systematic review following PRISMA guidelines of the English language literature from four electronic databases and academic search engines published from 2007 to 2018 was conducted. The papers were screened and assessed following predefined inclusive and exclusive criteria. The results were analyzed according to the research questions. Results: The findings revealed state-of-the-art in the NPD process and design process (n=4), the design methodology (n=23), and the resultant outcomes of empirical or clinical research in the validation stage (n=14) of medical device development (MDD). The findings also delineated existing studies in NPD, design process, and design methodologies aimed to ensure that medical devices would be effective and safe. Human factor engineering (HFE), cognitive method, ethnographic, and other methodologies were proposed to understand users, uses and context of use. Barriers, constraints, and multidisciplinary communication were addressed. Tools, processes, and methodologies were proposed to overcome the barriers. Conclusion: As home-use medical device development (MDD) and the adoption of IOT technology is now at a crossroads. This study addresses the necessity for future academic studies related to IOT adoption to MDD, including unique risks, multidisciplinary problems, emerging from IOT technology. Finally, future studies aimed at fabricating the NPD process or design process for IOT home-use medical devices to gain user acceptance were outlined